FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
PATHASSIST LED LIGHT FIBER
K Number: K141916
·
Decision Aug 7, 2014
Classifications
1
FEI Numbers
223
Registration Numbers
223
Same Product Code
64
Applicant Total
27
Review Days
23
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- PATHASSIST LED LIGHT FIBER
- K Number
- K141916
- Device Class
- FDA class 1
- Clearance Type
- Special
- Regulation Number
- 874.4420
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Entellus Medical, Inc.
- Date Received
- July 15, 2014
- Decision Date
- August 7, 2014
- Product Code
- LRC
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LRC | Instrument, Ent Manual Surgical | FDA class 1 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LRC), ordered by most recent decision date.
BB 8 Sinus Dilation Kit
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
VenSure LightGuide
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
SINUSPRIME Dilation System
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
Next Generation Balloon Dilation System
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
VenSure Balloon Device, VenSure Nav Balloon Device
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
Dillard Nasal Balloon Catheter
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
Other Clearances by Entellus Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K220027 | Audion ET dilation system | Apr 12, 2022 | Substantially Equivalent |
| K163509 | XprESS ENT Dilation System | Apr 5, 2017 | Substantially Equivalent |
| K163435 | Entellus Medical Reinforced Anesthesia Needle | Apr 5, 2017 | Substantially Equivalent |
| K152435 | PassAssist LED Light Fiber | Nov 20, 2015 | Substantially Equivalent |
| K152434 | XprESS Multi-Sinus Dilation System | Nov 20, 2015 | Substantially Equivalent |
| K142252 | XprESS Multi-Sinus Dilation Tool | Oct 17, 2014 | Substantially Equivalent |
| K133563 | PATHASSIST LIGHT SEEKER | Dec 20, 2013 | Substantially Equivalent |
| K132440 | XPRESS MULTI-SINUS DILATION TOOL | Oct 4, 2013 | Substantially Equivalent |
| K130503 | PATHASSIST LED LIGHT FIBER | Jun 11, 2013 | Substantially Equivalent |
| K121943 | XPRESS MULTI-SINUS DILATION TOOL | Aug 22, 2012 | Substantially Equivalent |